NCT04364945

Brief Summary

In this study, we compared the results of the intelligence and behavioral test performed after surgery between the group using sevoflurane and the group receiving dexmedetomidine and remifentanil, in Korean children under 2 years of age who underwent surgery under general anesthesia.

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
400

participants targeted

Target at P75+ for not_applicable

Timeline
32mo left

Started Jun 2020

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress69%
Jun 2020Dec 2028

First Submitted

Initial submission to the registry

April 24, 2020

Completed
4 days until next milestone

First Posted

Study publicly available on registry

April 28, 2020

Completed
2 months until next milestone

Study Start

First participant enrolled

June 17, 2020

Completed
8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 30, 2028

Expected
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2028

Last Updated

November 19, 2024

Status Verified

November 1, 2024

Enrollment Period

8 years

First QC Date

April 24, 2020

Last Update Submit

November 14, 2024

Conditions

Anesthesia and Neurotoxicity

Outcome Measures

Primary Outcomes (1)

  • Wechsler Preschool and Primary Scale of Intelligence-IV at age of 5

    categorization: 130 and above: Very Superior 120-129: Superior 110-119: High Average 90-109: Average 80-89: Low Average 70-79: Borderline

    When the patient's age is 5 years after surgery

Secondary Outcomes (3)

  • Leiter International Performance Scale at age of 30 months

    When the patient's age is 30 months old after surgery

  • Wechsler Preschool and Primary Scale of Intelligence-IV at age of 7

    When the patient's age is 7 years old after surgery

  • Child Behavior Checklist results

    When the patient's age become 30 months, 5 years and 7 years old after surgery

Study Arms (2)

Control group

PLACEBO COMPARATOR

General anesthesia is maintained using sevoflurane only. Sevoflurane concentration is adjusted to maintain bispectral index value between 40 and 60.

Drug: Sevoflurane

Dexmedetomidine-remifentanil(DEX-R) group

EXPERIMENTAL

General anesthesia is maintained using sevoflurane, dexmedetomidine (1 mcg/kg loading, and 1 mcg/kg/hr continuous infusion) and remifentanil (0.1-0.2 mcg/kg/min). Sevoflurane concentration is adjusted to maintain bispectral index value between 40 and 60.

Drug: dexmedetomidineDrug: remifentanilDrug: Sevoflurane

Interventions

dexmedetomidineDRUG

administration of dexmedetomidine 1 mcg/kg/hr

Dexmedetomidine-remifentanil(DEX-R) group
remifentanilDRUG

administration of remifentanil 0.1-0.2 mcg/kg/min

Dexmedetomidine-remifentanil(DEX-R) group
SevofluraneDRUG

Anesthesia is maintained using sevoflurane.

Control groupDexmedetomidine-remifentanil(DEX-R) group

Eligibility Criteria

Age1 Month - 23 Months
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Children under 2 years of age who underwent general anesthesia for elective surgeries inlcuding urology, surgery, plastic surgery, orthopedics, and otolaryngology, etc, which were non-staged and non-repetitive procedures
  • American Society of Anesthesiology Physical Status I, II

You may not qualify if:

  • Allergies to narcotic analgesics
  • With massive bleeding or shock
  • Heart, lung, kidney or liver disease
  • Central / peripheral nervous system disease and disorder
  • Any physical deformity and disorder, genetic disease, chromosomal disease
  • Previous history of general anesthesia or sedation
  • Developmental delay identified through K-DST results
  • Additional exposure to general anesthetics or sedative drugs during follow-up

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Seoul National University Hospital

Seoul, Other, 03080, South Korea

Location

Related Publications (1)

  • Ji SH, Kang P, Cho SA, Park JB, Jang YE, Kim EH, Kim JT, Kim HS, Jung HJ, Jung HA, Lee HC, Lee JH. Effects of Dexmedetomidine-Remifentanil on Neurodevelopment of Children after Inhalation Anesthesia: A Randomized Clinical Trial. Anesthesiology. 2025 Oct 1;143(4):827-834. doi: 10.1097/ALN.0000000000005634. Epub 2025 Sep 9.

    PMID: 40923823DERIVED

MeSH Terms

Conditions

Neurotoxicity Syndromes

Interventions

DexmedetomidineRemifentanilSevoflurane

Condition Hierarchy (Ancestors)

Nervous System DiseasesPoisoningChemically-Induced Disorders

Intervention Hierarchy (Ancestors)

ImidazolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsPropionatesAcids, AcyclicCarboxylic AcidsOrganic ChemicalsPiperidinesMethyl EthersEthersHydrocarbons, FluorinatedHydrocarbons, HalogenatedHydrocarbons

Study Officials

  • Ji-Hyun Lee, MD, PhD

    Seoul National University Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
CARE PROVIDER, OUTCOMES ASSESSOR
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Clinical Professor

Study Record Dates

First Submitted

April 24, 2020

First Posted

April 28, 2020

Study Start

June 17, 2020

Primary Completion (Estimated)

May 30, 2028

Study Completion (Estimated)

December 30, 2028

Last Updated

November 19, 2024

Record last verified: 2024-11

Locations

KR(1)